[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586723":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":49,"studyPopulation":49,"armGroups":59,"interventions":72,"overallOfficials":80,"centralContacts":84,"locations":93,"responsibleParty":112,"collaborators":115,"id":121,"slug":49,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":49,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":128,"maxAge":49,"enrollmentInfo":129,"targetDuration":49,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":95,"whyStopped":49,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"University of Illinois at Chicago","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":49},[9],{"measure":10,"description":11,"timeFrame":12},"Improvement of Corneal Epithelial Barrier and\u002For Integrity (Efficacy Outcome)","Proportion of subjects with improved epithelial barrier and\u002For integrity from baseline to DAY 56 as determined by the investigator on slit lamp examination: · Improved epithelial barrier, defined as ³ 50 % improvement in corneal fluorescein staining score using NEI grading scale · Improved epithelial integrity, defined as complete closure of persistent epithelial defect, measured with ImageJ on slit lamp images","Baseline to Day 56",[14,17,21,24,27,30,33,36,39,42,45,47],{"measure":15,"description":16,"timeFrame":12},"Visual Acuity","Percent change in best-corrected distance visual acuity from baseline to DAY 56 as measured using standard ETDRS protocols",{"measure":18,"description":19,"timeFrame":20},"Corneal staining and NEI grading","Grading of fluorescein staining of the cornea Minimum score = 0 Maximum score = 15 Lower score is better","Baseline to Day 70",{"measure":22,"description":23,"timeFrame":20},"Ocular Surface Parameters","Changes in ocular surface disease index (OSDI) from baseline to DAY 56 and DAY 70 Minimum value = 0 Maximum value = 100 Lower value is better",{"measure":25,"description":26,"timeFrame":20},"Corneal Epithelial Thickness","Percent change in corneal epithelial thickness from baseline to DAY 56 and DAY 70, as measured by anterior segment OCT (AS-OCT)",{"measure":28,"description":29,"timeFrame":20},"Subject Symptoms","Changes in ocular discomfort visual analog scale (VAS) 0 - 100, where 0 is no discomfort and 100 the worst discomfort, from baseline to DAY 70",{"measure":31,"description":32,"timeFrame":20},"Time to epithelial healing","Time of improvement of epitheliopathy",{"measure":34,"description":35,"timeFrame":12},"Corneal Opacities\u002FScars","Change in the size of corneal opacities and scars (if present) from baseline to DAY 56 as documented by slit lamp photographs",{"measure":37,"description":38,"timeFrame":12},"Corneal vascularization","Change in corneal vascularization on slit lamp photographs from baseline to DAY 56",{"measure":40,"description":41,"timeFrame":12},"Conjunctival injection","Change in conjunctival injection on slit lamp examination from baseline to DAY 56",{"measure":43,"description":44,"timeFrame":12},"Subbasal corneal nerve density","Changes in subbasal corneal nerve density on confocal microscopy from baseline to Day 56",{"measure":22,"description":46,"timeFrame":20},"Changes in Lissamine green staining from baseline to DAY 56 and DAY 70",{"measure":22,"description":48,"timeFrame":20},"Changes in anesthetic Schirmer's test from baseline to DAY 56 and DAY 70",null,{"allocation":51,"interventionModel":52,"interventionModelDescription":49,"primaryPurpose":53,"observationalModel":49,"timePerspective":49,"maskingInfo":54},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":55,"maskingDescription":49,"whoMasked":56},"DOUBLE",[57,58],"PARTICIPANT","INVESTIGATOR",[60,66],{"label":61,"type":62,"description":63,"interventionNames":64},"Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome","EXPERIMENTAL","Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome for Topical Eye Drop",[65],"Drug: Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome",{"label":67,"type":68,"description":69,"interventionNames":70},"Vehicle","PLACEBO_COMPARATOR","Vehicle (unconditioned media)",[71],"Other: Vehicle Control",[73,77],{"type":74,"name":61,"description":75,"armGroupLabels":76,"otherNames":49},"DRUG","Eye Drops",[61],{"type":6,"name":78,"description":75,"armGroupLabels":79,"otherNames":49},"Vehicle Control",[67],[81],{"name":82,"affiliation":5,"role":83},"Ali R Djalilian, MD","PRINCIPAL_INVESTIGATOR",[85,89],{"name":82,"role":86,"phone":87,"phoneExt":49,"email":88},"CONTACT","3129968937","adjalili@uic.edu",{"name":90,"role":86,"phone":91,"phoneExt":49,"email":92},"Charlotte E Joslin, OD","3129965410","charjosl@uic.edu",[94],{"facility":5,"status":95,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"RECRUITING","Chicago","Illinois","60612","United States","US",{"type":102,"coordinates":103},"Point",[104,105],-87.65005,41.85003,{"lat":105,"lon":104},[108],{"name":109,"role":86,"phone":110,"phoneExt":49,"email":111},"Jale Yucel","708-752-6905","zjyucel@uic.edu",{"type":83,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"Ali R Djalilian","Principal Investigator",[116,119],{"name":117,"class":118},"National Eye Institute (NEI)","NIH",{"name":120,"class":118},"National Institutes of Health (NIH)","100586723",false,"NCT06919081","Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease","Phase II Study of the Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease","Inclusion Criteria:\n\n* Age · Patients 18 years of age or older\n* Ocular Health\n\n  * Chronic corneal epithelial disease with fluorescein staining score 6 by NEI grading scale or persistent corneal epithelial defect present for longer than 14 days despite standard treatment\n  * No objective clinical evidence of significant (\\> 50%) improvement\u002Fworsening of the epithelial disease in the last 14 days\n  * Epithelial disease refractory to conventional non-surgical treatments (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops; anti-inflammatory therapy)\n  * If both eyes of subject meet the inclusion criteria, the eye with the higher fluorescein staining score will be enrolled to the study.\n* Study Procedures\n\n  * Only patients who satisfy all Informed Consent requirements may be included in the study. The patient and\u002For his\u002Fher legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients and\u002For legal representative must have been approved by the UIC IRB for the current study. Patients must have the ability and willingness to comply with study procedures.\n\nExclusion Criteria:\n\n* Ocular Health\n\n  * Any active or suspected ocular infection (bacterial, viral, fungal or protozoal).\n  * History of any ocular surgery (including laser or refractive surgical procedures) in the study eye within the 3 months prior to study enrollment.\n  * Treatment with Oxervate in the study eye within 12 months of enrollment.\n* Study Procedures\n\n  * Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein).\n  * Use of any investigational agent within 4 weeks of screening visit.\n  * Participation in another clinical study at the same time as the present study.\n  * Participants who are pregnant at the time of study enrollment.","ALL","18 Years",{"count":130,"type":131},24,"ESTIMATED","INTERVENTIONAL",[134],"PHASE2","In this phase II randomized double-masked clinical trials, subjects with non-resolving corneal epithelial disease\u002Fdefect (i.e., refractory to standard treatments for at least two weeks) will receive 8 weeks treatment of topical mesenchymal stem cell secretome or vehicle, with continued follow-up for up to Day 70.",[137,138],"Persistent Corneal Epithelial Defect","Corneal Epithelial Disorders",[140,141,142,143,144],"persistent corneal epithelial disease\u002Fdefects","persistent corneal epithelial","corneal epithelial disease","limbal stem cell deficiency","neurotrophic keratitis","2026-01-27",{"date":147,"type":148},"2026-01-29","ACTUAL",{"date":150,"type":148},"2025-08-01",{"date":152,"type":131},"2026-06-15",{"name":5,"class":6},1]